CHADDS FORD, Pa., Jan. 31, 2011 /PRNewswire/ — Endo
ENDP) announced today that its partners, Teikoku Seiyaku Co.,
Ltd. and Teikoku Pharma USA, Inc., have received a Paragraph
IV Certification Notice from Mylan Technologies Inc. advising of
the filing of an Abbreviated New Drug Application (ANDA) for a
generic version of LIDODERM® (lidocaine topical patch 5%).
The company is currently reviewing the details of this notice
from Mylan. Endo intends to vigorously defend LIDODERM’s
intellectual property rights and will pursue all available legal
and regulatory pathways in defense of LIDODERM.
The Paragraph IV certification notice refers to U.S. Patent Nos.
5,741,510 and 5,827,529, which cover the formulation of LIDODERM, a
topical patch to relieve the pain of postherpetic neuralgia
launched in 1999. These patents are listed in the U.S. Food and
Drug Administration’s (FDA) Orange Book and expire in March 2014
and October 2015, respectively.
With respect to Endo’s regulatory approach, the company
submitted a Citizen Petition in 2006 in reaction to a proposal by
FDA’s Office of Generic Drugs that would diverge from applicable
regulations and standards of practice regarding bioequivalence. The
company is requesting that the agency reconsider its departure from
its longstanding general rule of requiring clinical endpoint
bioequivalence studies for locally acting topical generic drug
products, including those that reference LIDODERM. To ensure the
safe and effective equivalence of any generic version to LIDODERM,
which acts locally in the skin, Endo believes that FDA must return
to its established standard of clinical endpoint bioequivalence
Endo Pharmaceuticals is a U.S.-based, specialty healthcare
solutions company, focused on high-value branded products and